Skip to main content

Non-compliance with deadlines by German authorities

 

The Regulation (EG) No. 1107/2009 establish decision deadlines for the regulatory authorities. In the zonal authorisation procedure the Member State examining the application (zRMS) shall decide within 12 months of receiving it whether the requirements for authorisation are met. If the zRMS needs additional information, this period shall be extendend by an additional period. That additonal period shall be a maximum of 6 months. The Member States concerned (cMS) shall decide on the application within 120 days. In the procedure of mutual recognition the Member State shall decide on the application within 120 days.

Even if the European Commission complainted already in 2016 the systematic non-compliance of these deadlines by German authorities (see DG(SANTE) 2016-8780 - MR)m), many application procedures are still affected by the non-compliance.

Should you have any questions concerning the non-compliance with deadlines by German authorities please contact Peter Koof or Dr. Alexander Koof.